Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries

NCT02959294 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: RGV GARM 5
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental causes. Typically defined as reversible head injury with temporary loss of brain function. Symptoms range from physical, cognitive, pain (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome. Use of AD-cSVF parenteral delivery to encourage repair of damage and decreased function following concussion, particularly in contact, repetitive sports injuries. Range of damage is measured in Grade I-III according to graduated severity. Unfortunately, less information is available about repetitive concussions and the long-term health issues.

Conditions

Traumatic Encephalopathies, Chronic; Concussion, Mild; Concussion, Intermediate; Concussion, Severe; Concussion, Brain

Keywords

TBI; mTBI; Concussion, Brain; Loss Consciousness, Traumatic; Headaches

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events

  Activities of Daily Living (ADL)

  Outcome measures at baseline at 6 month

• Cognitive Change in clinical symptoms associated with concussion-TBI

  Montreal Cognitive Assessment Scale (MCAS)

  Outcome measures at baseline and reviewed 1 year interval for average time 5 years

Secondary Outcomes (3)

• Beck's Depression Inventory (BDI)

  Annual for 5 years

• Adult Attention Deficit Assessment

  Annual for 5 years

• MRI Brain With & MRI Brain With & Without Contrast

  0, 3 years, 5 years

Study Arms (3)

Microcannula Harvest Adipose

EXPERIMENTAL

Acquisition Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via close syringe microcannula harvest from subdermal fat deposits

Procedure: Microcannula Harvest Adipose

Centricyte 1000

EXPERIMENTAL

Autologous AD-tSVF via enzymatic isolation/concentration via Centricyte 1000 Closed System to create AD-cSVF

Device: Centricyte 1000

Sterile Normal Saline

EXPERIMENTAL

Re-suspension of AD-cSVF pellet in Normal Saline deployment via IV

Procedure: Sterile Normal Saline IV deployment AD-cSVF

Interventions

Microcannula Harvest Adipose PROCEDURE

Use of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells

Microcannula Harvest Adipose

Centricyte 1000 DEVICE

Use of Centricyte 1000 Closed System Digestion Autologous AD-tSVF to create AD-cSVF

Centricyte 1000

Sterile Normal Saline IV deployment AD-cSVF PROCEDURE

Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use

Sterile Normal Saline

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented history of mTBI or TBI with Correlated MRI or CT
• At least 1 month post mTBI and TBI
• Able and Willing to participate in CT or MRI pre-study and at 3 year, 5 year interval
• Able to provide informed consent to undergo the study
• Depression, Cognitive Disability, Attention Disorders, Headaches or other persistent changes which followed a traumatic brain event (TBI)
• Impaired social or occupational functioning following mTBI or TBI
• History of repetitive events for mTBI and TBI

You may not qualify if:

• Documented history of neuro-degenerative illness, seizures, mental illness, or severe medical conditions preceding mTBI or TBI
• Malignances, Bleeding Disorders, Pregnancy or Lactation
• Tumors of Central Nervous System (CNS)
• Lack of adequate donor tissue volume as determined by the primary investigator at their discretion
• Any pre-existing medical condition which, in view of the primary investigator and patient's primary care physician, would prevent participation in study

Sponsors & Collaborators

• Robert W. Alexander, MD, FICS: lead

Study Sites (1)

Regenevita LLC

Stevensville, Montana, 59870, United States

Location

Related Publications (20)

• Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9.

  PMID: 18635021 BACKGROUND

• Parikh S, Koch M, Narayan RK. Traumatic brain injury. Int Anesthesiol Clin. 2007 Summer;45(3):119-35. doi: 10.1097/AIA.0b013e318078cfe7. No abstract available.

  PMID: 17622833 BACKGROUND

• Saatman KE, Duhaime AC, Bullock R, Maas AI, Valadka A, Manley GT; Workshop Scientific Team and Advisory Panel Members. Classification of traumatic brain injury for targeted therapies. J Neurotrauma. 2008 Jul;25(7):719-38. doi: 10.1089/neu.2008.0586.

  PMID: 18627252 BACKGROUND

• Kumar R, Husain M, Gupta RK, Hasan KM, Haris M, Agarwal AK, Pandey CM, Narayana PA. Serial changes in the white matter diffusion tensor imaging metrics in moderate traumatic brain injury and correlation with neuro-cognitive function. J Neurotrauma. 2009 Apr;26(4):481-95. doi: 10.1089/neu.2008.0461.

  PMID: 19196176 BACKGROUND

• Pellman EJ, Viano DC; National Football League's Committee on Mild Traumatic Brain Injury. Concussion in professional football: summary of the research conducted by the National Football League's Committee on Mild Traumatic Brain Injury. Neurosurg Focus. 2006 Oct 15;21(4):E12. doi: 10.3171/foc.2006.21.4.13.

  PMID: 17112190 BACKGROUND

• Heegaard W, Biros M. Traumatic brain injury. Emerg Med Clin North Am. 2007 Aug;25(3):655-78, viii. doi: 10.1016/j.emc.2007.07.001.

  PMID: 17826211 BACKGROUND

• Pearce JM. Observations on concussion. A review. Eur Neurol. 2008;59(3-4):113-9. doi: 10.1159/000111872. Epub 2007 Nov 30.

  PMID: 18057896 BACKGROUND

• Concussion (mild traumatic brain injury) and the team physician: a consensus statement. Med Sci Sports Exerc. 2005 Nov;37(11):2012-6. doi: 10.1249/01.mss.0000186726.18341.70. No abstract available.

  PMID: 16286874 BACKGROUND

• Hall RC, Hall RC, Chapman MJ. Definition, diagnosis, and forensic implications of postconcussional syndrome. Psychosomatics. 2005 May-Jun;46(3):195-202. doi: 10.1176/appi.psy.46.3.195.

  PMID: 15883140 BACKGROUND

• Maroon JC, Lovell MR, Norwig J, Podell K, Powell JW, Hartl R. Cerebral concussion in athletes: evaluation and neuropsychological testing. Neurosurgery. 2000 Sep;47(3):659-69; discussion 669-72. doi: 10.1097/00006123-200009000-00027.

  PMID: 10981754 BACKGROUND

• Randolph C. Baseline neuropsychological testing in managing sport-related concussion: does it modify risk? Curr Sports Med Rep. 2011 Jan-Feb;10(1):21-6. doi: 10.1249/JSR.0b013e318207831d.

  PMID: 21228656 BACKGROUND

• Binder LM. Persisting symptoms after mild head injury: a review of the postconcussive syndrome. J Clin Exp Neuropsychol. 1986 Aug;8(4):323-46. doi: 10.1080/01688638608401325.

  PMID: 3091631 BACKGROUND

• Thornton KE, Carmody DP. Efficacy of traumatic brain injury rehabilitation: interventions of QEEG-guided biofeedback, computers, strategies, and medications. Appl Psychophysiol Biofeedback. 2008 Jun;33(2):101-24. doi: 10.1007/s10484-008-9056-z. Epub 2008 Jun 13.

  PMID: 18551365 BACKGROUND

• Alexander MP. Mild traumatic brain injury: pathophysiology, natural history, and clinical management. Neurology. 1995 Jul;45(7):1253-60. doi: 10.1212/wnl.45.7.1253. No abstract available.

  PMID: 7617178 BACKGROUND

• De Beaumont L, Theoret H, Mongeon D, Messier J, Leclerc S, Tremblay S, Ellemberg D, Lassonde M. Brain function decline in healthy retired athletes who sustained their last sports concussion in early adulthood. Brain. 2009 Mar;132(Pt 3):695-708. doi: 10.1093/brain/awn347. Epub 2009 Jan 28.

  PMID: 19176544 BACKGROUND

• Cantu RC. Chronic traumatic encephalopathy in the National Football League. Neurosurgery. 2007 Aug;61(2):223-5. doi: 10.1227/01.NEU.0000255514.73967.90. No abstract available.

  PMID: 17762733 BACKGROUND

• Jordan BD. Chronic traumatic brain injury associated with boxing. Semin Neurol. 2000;20(2):179-85. doi: 10.1055/s-2000-9826.

  PMID: 10946737 BACKGROUND

• Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.

  PMID: 16983222 BACKGROUND

• Cantu RC. Second-impact syndrome. Clin Sports Med. 1998 Jan;17(1):37-44. doi: 10.1016/s0278-5919(05)70059-4.

  PMID: 9475969 BACKGROUND

• Borg J, Holm L, Peloso PM, Cassidy JD, Carroll LJ, von Holst H, Paniak C, Yates D; WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. Non-surgical intervention and cost for mild traumatic brain injury: results of the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. J Rehabil Med. 2004 Feb;(43 Suppl):76-83. doi: 10.1080/16501960410023840.

  PMID: 15083872 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Bronchiolitis Obliterans Syndrome; Brain Concussion; Headache

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Head Injuries, Closed; Wounds, Nonpenetrating; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert W. Alexander, MD

  GARM International and GARM USA

  PRINCIPAL INVESTIGATOR

• Glenn C Terry, MD

  GARM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: November 30, 2018
• Primary Completion: November 1, 2023
• Study Completion: March 1, 2024
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

US (1)